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Completed

NCT Number: NCT04838262

Stress and the Sympathetic Nervous System in Adults With Depression

To test our hypotheses, we will enroll healthy adults having no history of mood disorders and adults with major depressive disorder (MDD) having a broad range of depressive symptom severity. After screening, subjects will meet with the research coordinator or an investigator for a discussion, with opportunity for questions, before applicable consent forms are obtained. Daily stress processes will be assessed using an ecological momentary assessment approach for 8 consecutive days. On the last day of the daily stress assessment, we will directly measure muscle sympathetic nerve activity, blood pressure, and heart rate during acute laboratory-based cognitive, emotional, and physiological interventions to induce a stress response. A venous blood sample will be taken for measurements of metabolic and renal health and systemic inflammation.

Aim 1: To examine the effect of daily psychosocial stressor exposure on acute sympathetic stress reactivity in MDD. Two stressor exposure indicators will be calculated: stressor frequency (i.e., percentage of interview days during which at least one stressor occurred) and total stress (i.e., total number of stressors reported across all interview days) and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults.

Aim 2: To determine the relation between negative affective reactivity to daily psychosocial stressor exposure and acute sympathetic stress reactivity in MDD. Negative affective reactivity will be calculated as the change in affect on days when stressors occurred compared to one's typical affect on non-stressor days and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Arlington

Arlington, Texas, 76010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants will be 18-30 yrs.
  • Healthy non-depressed men and women will have no history or evidence of psychiatric illness and will not have a family history of MDD or major psychiatric illness.
  • Men and women with MDD will have symptomatic depression that meets diagnostic criteria and will be non-medicated.
  • The capacity and willingness to provide written informed consent, to attend all study related visits, and to comply with the study protocol.

Exclusion criteria

Subjects will be excluded at the discretion of the PI/collaborating clinician or for any of the following reasons:

  • psychiatric illness aside from MDD (including current or past psychotic disorders, bipolar disorder, schizophrenia or schizoaffective disorder, panic disorder, post-traumatic stress disorder, obsessive compulsive disorder)
  • subthreshold depression
  • current use of psychotropic medications (including major classes of antidepressants, anxiolytics, antipsychotics, mood stabilizers)
  • active suicidal or homicidal ideation
  • active substance dependence or eating disorders
  • current use of any medications that could alter sympathetic reactivity
  • diagnosed or suspected cardiovascular, renal, or metabolic disease (hypertension, heart disease, diabetes, hyperlipidemia)
  • autonomic disorders
  • tobacco use (including electronic cigarettes)
  • obesity (body mass index > 30 kg/m2)
  • breastfeeding or pregnancy
  • <18 or >30 yrs

Treatment and study plan

Acute Stressors

Other

Sympathetic nervous system activity and blood pressure will be measured before, during, and after several acute laboratory-based cognitive (Stroop Color Word Test), emotional (International Affective Picture System), and physiological (Cold Pressor Test) stressors.

Primary outcomes

  1. Percent of Days Participants Report Stressors

    Time frame: 8 days before intervention

    the percentage of days that participants reported stressors over the course of 8 days before the intervention, measured each day via self-report using ecological momentary assessment

  2. Negative Affective Reactivity to Daily Stressors

    Time frame: 8 days before intervention

    Negative affect was measured each day via self-report using ecological momentary assessment using Positive and Negative Affect Schedule (possible range 1-5 arbitrary units, AU), and negative affective reactivity score was defined as the magnitude of the change in negative affect on days when stressors occurred compared to negative affect on non-stressor days over the 8-day timeframe. A singe negative affective reactivity score was calculated for each participant using two-level multi-level modeling (within person slopes). This outcome was operationalized as described in the funded grant and does not have a scale/construct name. There is no defined/set range: more negative slopes indicate a paradoxical increase in negative affect on stressor days, whereas more positive slopes indicate a greater decline in negative affect on stressor days.

  3. Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity)

    Time frame: 3 minutes after each laboratory-based intervention

    muscle sympathetic nerve activity was measured using microneurography and the change was calculated as the difference between the mean value during baseline and during the mean value during each of three laboratory-based interventions (cold pressor test, Stroop color word test, International Affective Picture System); a larger value indicates a greater increase in sympathetic activity

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Penn State University

Registry information

Official study title

Daily Stress Processes and Sympathetic Reactivity in Depression

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2021
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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